ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT— 510(k) K884026

Name: FDA 510(k) clearance K884026
Creator: U.S. Food and Drug Administration
Published: 1989-02-03

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K884026 for ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT, Substantially Equivalent on 1989-02-03. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1988-09-23
Decision date: 1989-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNA

view all

K071799 — MODIFICATION TO BIOSTAR OIA SHIGATOX2007-10-02
K031367 — DUOPATH VEROTOXINS GLISA TEST2004-01-23
K993401 — DRYSPOT E.COLI 0157 KIT2000-02-28
K981734 — VTEC-RPLA SEIKEN1998-09-22
K962028 — WELLCOLEX E-COLI OI57 ZC601996-11-01

More clearances from Oxoid U.S.A., Inc.

view all

K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM1989-06-09
K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
K874303 — STAPHYLASE TEST1987-11-06
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10
K872135 — MCBRIDE MEDIUM CM 8191987-06-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.